The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Multi Calibrator.
| Device ID | K110251 |
| 510k Number | K110251 |
| Device Name: | SYNCHRON MULTI CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea, CA 92821 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea, CA 92821 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-28 |
| Decision Date | 2011-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590233037 | K110251 | 000 |